Your Role:

You are an experienced professional with a strong background in Regulatory Affairs, dedicated to enhancing data quality and compliance within the pharmaceutical industry. You possess a solid understanding of regulatory processes and are adept at managing teams to support the regulatory lifecycle.

Who You Are:

Minimum Requirements:

• Experience: At least 8 years of professional experience in the pharmaceutical, service provider, or IT industry, with a minimum of 6 years in Regulatory Affairs.
• Education: Basic degree in a scientific discipline or related work experience in the chemical-pharmaceutical industry.

Maximum Requirements:

• Manage the Regulatory Information Management (RIM) team to support regulatory lifecycle management.
• Lead Regulatory Data Quality initiatives and ensure compliance across VEEVA Vault and related systems.
• Conduct regular assessments of data quality metrics, ensuring adherence to established standards.
• Identify root causes of issues related to processes, systems, or personnel.
• Drive data cleansing activities and implement innovative technology solutions to enhance regulatory processes, including automation and AI projects.
• Collaborate with Global Regulatory Affairs and cross-functional teams to improve data quality and process efficiency.
• Promote data literacy and Data Governance among stakeholders.
• Ensure compliance with health authority data submission requirements, maintaining consistency across all submissions.
• Communicate effectively with stakeholders to support regulatory objectives.
• Ensure regulatory data accuracy, completeness, and compliance with global standards (e.g., IDMP, xEVMPD).